CE Marking for Medical Devices: Is there a CE Certification?

Medical devices have to bear a CE mark. This hold true also for toys and elevators and many other product classes.

What does this CE mark stand for? Is there something like a "CE certification" for medical products or other devices? This article gives answers.

CE Mark: What it actually stands for

Originally CE stood for Communauté Européenne (European Community) later for Conformité Européenne. With the CE mark a manufacturer expresses conformity with the European legislation in particular with European directives and European regulations.

In case of medical devices there are (or have been) the Medical Device Directive MDD, the Active Implantable Medical Device Directive AIMDD and the In-vitro Device Directive IVDD.

These directives are going to be replace by the Medical Device Regulation MDR and the In-vitro Device Regulation IVDR. But still the manufacturers themselves declare conformity and affix the CE mark (sometimes also referred to as "CE label").

Preconditions for CE Marking

a) Medical device meets requirements (by MDD respectively MDR)

The first precondition that a manufacturer affixes the CE mark is, that the medical device fulfills are "essential requirements" as laid out in Annex I of MDD respectively the "general safety and performance requirements" as laid out in Annex I of MDR.

Is there a "CE Certification"?

Actually, there is no CE Certification. There is no agency like the FDA or the European Medicine Agency approving or certifying medical devices.

However, there are other types of certificates issued by the notified bodies:

For medical devices of class IIa or higher typically a certified QM system is required. E.g. there is a ISO 13485 certification.

Additionally these manufacturers have to prove conformity with the annexes of MDR / MDR describing the requirements a quality management system has to meet. These requirements are not exactly identical with the ISO 13485 requirements. Therefore notified bodies additionally have to issue annex certificates.

Even there is not CE certification or CE certificate, this term is commonly used for medical devices that successfully passed the conformity assessment procedure and that are legally labeled with a CE mark.

Comparison of European and FDA approval processes

Latest with the switch from the European directives to the European regulations the efforts for the European and FDA approval processes are about the same:

In Europe manufacturers are not quite in such a weak positions as in the US. The outcome of both approaches in terms of incidents and patient safety are about the same, the overhead and unpredictability of the process used to be higher in the US.

Do you want to market your medical device in Europe or the US?

We at the Johner Institute are specialized in providing support for manufacturers of medical devices that contain software or that are standalone software. We can help to: